MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 2X18IN 5 S/A V-40; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M656G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record review was performed for the finished device batch mch954 and no non-conformance were identified.
Event or Problem Description
It was reported that the patient underwent a cardiovascular procedure on (b)(6) 2019 and suture was used.The needle pulled off the suture during use.The broken piece was retrieved from the patient.Changed another one to complete the procedure.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Investigation summary: it was received for analysis an opened sample of product code: m656, lot: mch954.The product code is multi-strands and required two strands per packet.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, no performance pull off suture needle was found and the tested samples met the finished goods requirements.

• Brand Name: STLESS STEEL SIL 2X18IN 5 S/A V-40
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8556185
• Report Number: 2210968-2019-80748
• Device Sequence Number: 1730740
• Product Code: GAQ
• UDI-Device Identifier: 10705031045507
• UDI-Public: 10705031045507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: M656G
• Device Lot Number: MCH954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 12/18/2019
• Patient Sequence Number: 1